Status:
RECRUITING
Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
The Leukemia and Lymphoma Society
Conditions:
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Brief Summary
Blood cancers occur when the molecules that control normal cell growth are damaged. Many of these changes can be detected by directly examining parts of the cancer or cells in blood. Several alteratio...
Detailed Description
The purpose of this research study is to perform these molecular analyses on tissues (obtained from biopsies), blood, or other body fluids such as saliva. Importantly, this study will use tissue speci...
Eligibility Criteria
Inclusion
- Patients with Known or Suspected Precursor Hematological Cancer
- Including the following subgroups of diseases:
- Early MDS, including pathologically-confirmed MDS (IPSS Low/Int-1; IPSS-R Very Low/Low) and idiopathic cytopenias of undetermined significance (ICUS);
- Asymptomatic Multiple Myeloma and Waldenstrom Macroglobulinemia such as monoclonal gammopathy of undermined significance (MGUS) or Smoldering Multiple Myeloma (SMM or SWM);
- Monoclonal B cell lymphocytosis (MBL);
- Early stage asymptomatic low-grade lymphomas; or
- Other precursor conditions or clonal genetic abnormalities of the blood/bone marrow that do not meet criteria for symptomatic hematological malignancy, or patients exposed to prior chemotherapies (e. g., alkylating agents, platinum derivatives, taxanes, topo-2 inhibitors, anti-metabolites, systemic radioisotopes).
- Patients must be at least 18 years of age to participate in this research.
- Inclusion of Women and Minorities -- In accordance with NIH guidelines, women and members of minority groups and their subpopulations will be included in this protocol.
Exclusion
- Patients with Known or Suspected Precursor Hematological Cancer are NOT EXCLUDED
- Evidence of symptomatic or active hematological malignancy. Patients enrolled on clinical trials for precursor diseases are NOT excluded from this study.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT02269592
Start Date
August 1 2014
End Date
September 1 2030
Last Update
December 1 2025
Active Locations (7)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Dana Farber Cancer Institute at St. Elizabeth's
Brighton, Massachusetts, United States, 02135
3
Dana Farber Cancer Institute at Merrimack Valley
Methuen, Massachusetts, United States, 01844
4
Dana Farber Cancer Institute at Milford Regional Medical Center
Milford, Massachusetts, United States, 01757